Y-Stent with Tracheal Posts with 1mm Wall Thickness

GUDID 00815347020082

E. Benson Hood Laboratories Y-Stent

HOOD, E BENSON LABORATORIES INC

Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use Tracheostomy tube, non-reinforced, non-customized, single-use

Primary Device ID	00815347020082
NIH Device Record Key	89ccdb12-ed01-44f3-ba82-b4fb180dedbc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Y-Stent with Tracheal Posts with 1mm Wall Thickness
Version Model Number	YS1-1512-S
Company DUNS	076603380
Company Name	HOOD, E BENSON LABORATORIES INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815347020082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K873742

FDA Product Code

NWA	Prosthesis, Tracheal, Preformed/Molded